Tip Set: 3x 1I

GUDID J021063705001

Tip Set for Proxeo ULTRA

W & H Dentalwerk Bürmoos GmbH

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: J021063705001
• NIH Device Record Key: e3b57bb3-b252-4bb2-a262-ee7c7ee6d4ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tip Set: 3x 1I
• Version Model Number: 06370500
• Company DUNS: 300238441
• Company Name: W & H Dentalwerk Bürmoos GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J021063705001 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

[J021063705001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-22
• Device Publish Date: 2023-08-14

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

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• J021100355010 - ZA-55 Scaler: 2024-08-08 ZA-55 Scaler without light
• J021100355020 - ZA-55 LM Air Scaler: 2024-08-08 Air Scaler with light
• J021100355030 - ZA-55 M Scaler without light: 2024-08-08 Air Scaler without light
• J021100355110 - SF1LM KO Air Scaler: 2024-08-08 Brasseler Air Scaler
• J021100355120 - SF1LM A1 Air Scaler: 2024-08-08 Air Scaler Brasseler
• J021100355311 - ZA-55 Synea Scaler: 2024-08-08